Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors

PRIMARY OBJECTIVES:

I. To assess the effect of a home-based aerobic and resistance exercise and nutrition
education intervention in overweight or obese, sedentary, older (65 years and above) breast
cancer survivors on physical function (6-minute walk test) and quality of life compared to
standard of care.

SECONDARY OBJECTIVES:

I. To assess the effect of a home-based aerobic and resistance exercise and nutrition
education intervention on diet quality, sleep, anxiety, depression, source of motivation for
exercise, and immune function in overweight or obese, sedentary, older (65 years and above)
breast cancer survivors compared to standard of care.

EXPLORATORY OBJECTIVES:

I. To determine how body composition (dual X-ray absorptiometry [DEXA]) and weight
maintenance are affected by a 12-week aerobic and resistance exercise training program among
older (65 years and above), sedentary, overweight and obese breast cancer survivors.

II. To compare differences in the above outcomes among older (65 years and above), sedentary,
overweight and obese breast cancer survivors who completed a home-based aerobic and
resistance exercise training program versus those who did not receive the intervention,
standard of care.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (ACTIVE TREATMENT): Participants complete a home-based aerobic and resistance
exercise program and receive nutrition education for 12 weeks.

GROUP II (WAITLIST): Participants are placed on a waitlist for 12 weeks and then complete a
home-based aerobic and resistance exercise program and receive nutrition education for 12
weeks.

Inclusion Criteria:

- History of breast cancer who have completed treatment >= 6 months ago (not including
hormonal therapy, Zometa, or other non-chemotherapy/radiation cancer treatment at the
discretion of the principal investigator)

- Physically inactive, defined as not meeting the United States (U.S.) Center for
Disease Control and Prevention?s physical activity guidelines for cancer survivors
(150 minutes or 2 hours and 30 minutes a week of moderate-intensity exercise)

- Overweight or obese, defined as having a body mass index (BMI) between 26 kg/m^2 and
40 kg/m^2, inclusive

- Meeting criteria for participation in low to moderate risk exercise based on the
American College of Sports and Medicine (ACSM) guideline

- Providing informed consent indicating understanding the investigational nature of this
study by signing an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedures

Exclusion Criteria:

- Metastatic breast cancer

- Orthopedic or neuromuscular disorders that preclude participation in exercise

- Any history of myocardial infarction (MI), angina pectoris, or congestive heart
failure

- High risk for moderate exercise based on ACSM risk classification

- Pregnant or nursing

- Unwilling or unable to follow protocol requirements

- Any condition which - in the investigator?s opinion - deems the participant an
unsuitable candidate to participate in this study